Préface CSA Ce document constitue la première édition de la CAN/CSA-Z17665-1, Stérilisation des produits de santé - Chaleur humide - Partie 1: Exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation des dispositifs médicaux. Il s’agit de l’adoption, avec exigences propres au Canada, de la norme ISO (Organisation internationale de normalisation) Z17665-1 (première édition, 2006-08-15), qui porte le même titre. Cette norme remplace CAN/CSA-ISO 11134-98, Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization (norme ISO 11134:1994 adoptée). Cette norme a été révisée en vue de son adoption pour le Canada par le Comité technique CSA sur la stérilisation, sous l’autorité du Comité directeur stratégique sur la technologie des soins de santé, et a été approuvée par le Comité technique. Cette norme a été approuvée en tant que Norme nationale du Canada par le Conseil canadien des normes. Domaine d'application 1.1 Éléments inclus 1.1.1 La présente partie de l'ISO 17665 spécifie les exigences relatives au développement, à la validation et au contrôle de routine du procédé de stérilisation des dispositifs médicaux à la chaleur humide. NOTE Bien que le domaine d'application de la présente partie de l'ISO 17665 se limite aux dispositifs médicaux, les exigences qu'il spécifie et les directives qu'il donne peuvent s'appliquer à d'autres produits de santé. 1.1.2 Les procédés de stérilisation à la chaleur humide auxquels la présente Norme internationale s'applique sont les suivants, sans toutefois s'y limiter: a) systèmes d'évacuation de la vapeur saturée; b) systèmes d'évacuation forcée de l'air/vapeur saturée; c) mélanges air/vapeur; d) vaporisation d'eau; e) immersion dans l'eau.
SDO | CSA: Canadian Standards Association |
Document Number | |
Publication Date | March 7, 2024 |
Language | fr - French |
Page Count | |
Revision Level | |
Supercedes | |
Committee |
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